NCT05108844 Early Videocapsule Endoscopy for Upper Gastrointestinal Bleeding
| NCT ID | NCT05108844 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alberta |
| Condition | Small Bowel Bleeding |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2021-09-01 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2021-09-01 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years * New onset of acute gastrointestinal bleeding defined as: 1. The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS 2. Hemoglobin drop of ≥ 20 g/L from patient's baseline * Have capacity to consent * Hemodynamically stable (i.e. blood pressure \>100/60 or pulse \<110 at the time of consent) * Initial gastroscopy negative for active bleeding or potential bleeding source Exclusion Criteria: * Inability to provide consent due to lack of capacity, language barrier or other reasons * Pregnant women * Prior history of small bowel surgery * Prior history of Crohn's disease * Prior history of small bowel or colonic strictures * Prior history of abdominal radiation
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05108844 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Small Bowel Bleeding. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05108844 currently recruiting?
Yes, NCT05108844 is actively recruiting participants. Contact the research team at zepedago@ualberta.ca for enrollment information.
Where is the NCT05108844 trial being conducted?
This trial is being conducted at Edmonton, Canada.
Who is sponsoring the NCT05108844 clinical trial?
NCT05108844 is sponsored by University of Alberta. The trial plans to enroll 70 participants.